Endoscopy tube and device for cryotherapy

ABSTRACT

An endoscopy device is configured with a flexible cannula or tube for nasal insertion and has multiple parallel and adjacent lumens that provide sub-chambers configured to provide means to diagnose and treat Barrett&#39;s esophagus, such as by spray cryo-therapy with no further insertion of tubes. The lumens are configured to impart a small diameter with sufficient flexibility for nasal insertion into a patient&#39;s esophagus and accommodate a means any treatment modality. In the case of cryo-therapy, a lumen provides gas pressure relief, and is along the tube, with separate lumens for the delivery of a liquid freezing agent and an imaging means, which includes a source of illumination. Outer lumens may support guide wires used to steer the tube tip and aim the camera to determine the where to immobilize tip before the start of the treatment and/or to correct strictures formed in prior procedures.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of priority to the USProvisional patent application of the same title that was filed on Feb.6, 2018, having application Ser. No. 62/626,683 and is incorporatedherein by reference.

BACKGROUND OF INVENTION

The field of inventions is endoscopes and related catheter devices, andmore specifically such endoscopes configured for treatment of variousmedical conditions.

Endoscopes are well known in the art for diagnostic, treatment andsurgical purposes.

Depending on the route of entry and the need for surgical incisions tocreate entry routes other than natural body cavities, a treatment mayrequire sedation to keep the patient still an/or avoid pain anddiscomfort. Endoscopes generally refer to tubular and catheter typedevices that are inserted via natural body cavities, whereas similardevices inserted through surgical opening are generally referred to aslaparoscopes.

It would be advantageous to perform many procedures without sedation ina clinic, but rather in the office of the treating physician to saveboth patient and physician time and reduce costs.

Sterilization of endoscopes and catheters, tubes and lumens they deployis a barrier to office treatment, requiring special equipment andmultiple devices.

Some treatment modalities use multiple catheters and a single endoscopefor finding and viewing the tissue of interest for treatment, adding tothe complexity of treatment, and the need for multiple sterile deviceson hand.

According it has been recognized that there are multiple barriers toenabling more in office treatments.

Accordingly, it is an object of the invention to provide for endoscopicprocedures without a needs for sterilization by configuring thecatheters, tubes and lumens associated therewith so that they can bemade at least partially disposable in a compact form that is easy forthe treating physician to manipulate.

The above and other objects, effects, features, and advantages of thepresent invention will become more apparent from the followingdescription of the embodiments thereof taken in conjunction with theaccompanying drawings

SUMMARY OF INVENTION

In the present invention, the first object is achieved by providing aflexible tubular member for endoscopic procedures, the membercomprising: a tube having a proximal end and an opposing distal end withan outer wall extending between the ends, the tube having an outerdiameter of less than about 10 mm, multiple parallel lumens that extendgenerally between the proximal and distal ends of the tube, including;at least one lumen having a plurality of perforations through the outerwall adjacent the distal end of the tube, a pair of guide wires disposedto extend from about the distal end of the tube to the proximal end ofthe tube, two or more remaining lumens for an imaging means and a fluidspray means.

A second aspect of the invention is characterized by such a flexibletubular member for endoscopic procedures that is further comprising aninflation fixation means disposed at least about 10 mm from the distalend of the tube.

Another aspect of the invention is characterized by any such flexibletubular member for endoscopic procedures wherein the multiple parallellumens that extend generally between the proximal and distal ends of thetube, include; a first central lumen with a bore of a first diameterthat disposed within a ovoid member, the ovoid member being connected ata top and bottom to the outer wall of the tube, a second central lumenwith a bore of a second diameter that is smaller than the firstdiameter, the second lumen being disposed within the ovoid member andadjacent to the first central member, wherein the at least one lumenhaving a plurality of perforations through the outer wall adjacent thedistal end of the tube comprises a pair of generally lobe shapedelongated lumens, each being disposed between opposing side of the outerwall of the tube and an adjacent side of the ovoid member, one of saidpair being the first lumen having a plurality of perforations throughthe outer wall adjacent the distal end of the tube, and the other of thepair being an additional lumen having a plurality of perforationsthrough the outer wall adjacent the distal end of the tube.

Another aspect of the invention is characterized by any such flexibletubular member for endoscopic procedures wherein each of the guide wiresof the pair are disposed in an opposite side of the outer wall of thetube adjacent each of the lobe shaped elongated lumens in which eachguide wire is surround by tube outer wall such that an inner portion ofthe tube wall projects as a protuberance into each of the generally lobeshaped elongated lumens to narrow the width of each of the generallylobe shaped elongated lumens adjacent the guide wire in the tube wall.

Another aspect of the invention is characterized by any such flexibletubular member for endoscopic procedures wherein the first central lumenhas a discharge portal adjacent the distal end of the tube and areceiving portal at the proximal end of the tube.

Another aspect of the invention is characterized by any such flexibletubular member for endoscopic procedures that has a length of at leastabout 55 cm.

Another aspect of the invention is characterized by any such flexibletubular member for endoscopic procedures that has a length of less thanabout 115 cm.

Another aspect of the invention is characterized by any such flexibletubular member for endoscopic procedures wherein the tube is an outersheath and the lumen for imaging is a sealed lumen of the outer sheath,the sealed lumen having an optically transparent window at the distalend of the tube in which the guide wires are coupled to the imagingmeans and co-disposed in the sealed lumen, and the sheath provides thepair of the first and a second lumen and the lumen for the fluid spraymeans.

Another aspect of the invention is characterized by any such flexibletubular member for endoscopic procedures that has an outer diameter ofless than about 10 mm.

Another aspect of the invention is characterized by any such flexibletubular member for endoscopic procedures wherein the one of the two ormore remaining lumen is configured to provide the fluid spray means andhas an interior cross-sectional area transverse to the lumen of at leastabout 6 mm².

Another aspect of the invention is characterized by any such flexibletubular member for endoscopic procedures wherein the lumen for the fluidspray means comprises a heating means.

Another aspect of the invention is characterized by any such flexibletubular member for endoscopic procedures wherein the plurality ofperforations through the outer wall adjacent of the tube are disposedbetween the inflation fixation means and the distal end of the tube.

Another aspect of the invention is characterized by a method of treatinga patient comprising the steps of providing a flexible tube having; aproximal end and an opposing distal ends with an outer wall extendingbetween the ends, multiple parallel lumens that extend generally betweenthe proximal and distal ends of the flexible tube, including at least afirst lumen adjacent the outer wall of the flexible tube, a plurality ofperforation in the outer wall of the flexible tube that penetrate to thefirst lumen, wherein the first lumen has an upper vent portal adjacentthe proximal end, providing a patient, introducing the distal end of theflexible tube through the nose of the patient into a nasal cavity,advancing the flexible tube from the nasal cavity into the esophagus,identifying an area of the esophagus to be treated, fixing the flexibletube such that the distal end of the tube is disposed adjacent to thearea to be treated, introducing a liquid freezing agent into theproximal end of the tube for delivery via at least one of the multipleparallel lumen to exit a fluid spray means at the distal end of thetube, whereas a gaseous form of the liquid freezing agent that expandson warming can flow toward the proximal end of the tube via by enteringthe first lumen via the plurality of perforations therein.

Another aspect of the invention is characterized by such a method oftreating a patient wherein the at least one of the multiple parallellumen to provided as an exit for the fluid spray means at the distal endof the tube has a heating means.

Another aspect of the invention is characterized by any such method oftreating a patient wherein the plurality of perforations through theouter wall of the tube that penetrate to the first lumen are disposedbetween the inflation fixation means and the distal end of the tube.

Another aspect of the invention is characterized by a method of using anendoscopy tube comprising the steps of preparing an endoscopy device by;providing a tubular member comprising; a tube having a proximal end andan opposing distal ends with an outer wall extending between the ends,multiple parallel lumens that extend generally between the proximal anddistal ends of the tube, including at least a first lumen adjacent theouter wall of the tube, a plurality of perforation in the outer wall ofthe tube that penetrate to the first lumen, wherein the first lumen hasan upper vent portal adjacent the proximal end, a second lumen that isopen at a proximal end and closed at a distal end and having anoptically transparent window at the distal end of the tube, a thirdlumen open at the proximal end and the distal end for transporting aliquid freezing agent to a region to be treated, providing an endoscopytube having; a steering means, an imaging means disposed at the distalend of the endoscopy tube, and an illumination means disposed at thedistal end of the endoscopy tube, inserting the distal end of the end ofthe endoscopy tube within the second lumen of the tubular member at theopen proximal end, advancing the distal end of the endoscopy tube withinthe second lumen toward the distal end of the second lumen to disposethe imaging and illumination means adjacent to the optically transparentwindow for illuminating and obtaining images of tissues exterior to thetubular member and the tubular member covers the endoscopy tube, whereinsaid step of advancing provides a covered endoscopy tube, inserting thecovered endoscopy tube in a body cavity of a patient, performing atreatment procedure that includes applying a quantity of liquid freezingagent to an area to be treated and obtaining images of the area to betreated at least after the treatment is performed, removing the coveredendoscopy tube from the body cavity, removing the tubular member fromthe endoscopy tube, disposing of the tubular member.

Another aspect of the invention is characterized by such a method ofusing an endoscopy tube wherein the covered endoscopy tube is insertedinto a body cavity of a patient from the nasal cavity of the patient andthe body cavity is the esophagus.

Another aspect of the invention is characterized by any such method ofusing an endoscopy tube wherein the covered endoscopy tube is insertedinto a body cavity of a patient from the mouth of the patient and thebody cavity is at least one lung.

Another aspect of the invention is characterized by any such method ofusing an endoscopy tube wherein the third lumen comprises a heatingmeans.

Another aspect of the invention is characterized by any such method ofusing an endoscopy tube wherein the interior of the third lumen has across-sectional area transverse to the lumen of at least about 6 mm².

The above and other objects, effects, features, and advantages of thepresent invention will become more apparent from the followingdescription of the embodiments thereof taken in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a schematic perspective view of an endoscope and controller

FIG. 2 is another perspective view of the endoscope and controller inFIG. 1.

FIG. 3A is perspective view of the distal end of another embodiment ofthe endoscope showing a balloon in a collapsed state, whereas FIG. 3Billustrates the balloon in an inflated state.

FIG. 4 is an isometric view for the tip or distal end of the catheterportion of the device in the FIG. 1-3 in a straightened or linearconfiguration.

FIG. 5 is a transverse cross section view of the tip in FIG. 4.

FIG. 6 is an isometric view of the tip of another embodiment with a “D”shaped control and imaging member for insertion in the disposable sheathshown in FIG. 7.

FIG. 7 is an isometric view of the tip of an embodiment of such adisposable sheath.

FIG. 8 is an axially disposed longitudinal cross sectional elevationview of the tip of an embodiment of such a disposable sheath.

FIG. 9 is an offset axially disposed longitudinal cross sectionalisometric view of the tip of an embodiment of such a disposable sheath.

FIG. 10 is a different offset axially disposed longitudinal crosssectional elevation view of the tip of an embodiment of such adisposable sheath.

FIG. 11A is isometric cut-away view of the embodiment of the sheath inFIG. 10 and FIGS. 11B and 11C are transverse section views of differentportions thereof.

FIG. 12 is a cut away perspective view of the sheath including theinserted “D” shaped member illustrated with surface shading.

FIG. 13A is an isometric view of another embodiment of the invention inwhich a heating element is disposed within the tube of FIG. 4-5 at thetip, whereas FIG. 13B illustrates an alternative position for theheating element and FIG. 13C illustrates another embodiment in which theheating element is deployed in the sheaf type tube of FIG. 12.

FIG. 14A is a schematic diagram showing an electrical connection of theheater element to the controller, whereas FIG. 14B is an enlarged viewof the distal end of the tube showing the connection of wiring to theheater element.

FIG. 15A is an external elevation of the portion of the catheter tubewith the fixation and expansion means; FIG. 15B is a transversesectional elevation at section line B-B when the balloon portion in FIG.15A is inflated, as shown in the perspective view in FIG. 15C.

FIG. 16A is a longitudinal sectional view of the inflated balloon inFIG. 15A-C, wherein FIG. 16B is a similar section view of the inflatedballoon in another embodiment in which an imaging means is disposed inthe balloon.

FIG. 17A is isometric view of another embodiment of the invention inwhich a second imaging means is disposed in a position to the view theimaging means at the distal and the balloon member, whereas FIG. 17B isa longitudinal sectional isometric view thereof with the ballooninflated.

FIG. 18 is a schematic diagram of the device in signal communicationwith a portable display monitor.

FIG. 19 is a transverse cross-section view of the balloon inflatorsurrounding the tube of another embodiment related to FIGS. 4 and 5.

FIG. 20 is an alternative embodiment of the inflator surrounding thetube in FIG. 19.

FIG. 21 is a isometric view of another embodiment of the inventionshowing an applicator tip advanced beyond the imaging means at thedistal end of the tube.

FIG. 22A is an exploded isometric view of another embodiment of theinvention showing the applicator tip and end portion for the connectedtube, whereas FIG. 22B is a transverse section of the tube at sectionline B-B in FIG. 22A.

FIG. 23 is a transverse cross sectional view of another embodiment ofthe tube.

FIG. 24A is a transparent perspective view of the sheath including theinserted “D” shaped member and FIG. 24B is transverse section view atthe interface of the permanent member and the lumen of the sheathcontaining it and the guidewires.

DETAILED DESCRIPTION

Referring to FIGS. 1 through 23, wherein like reference numerals referto like components in the various views, there is illustrated therein anew and improved endoscopy device, generally denominated 1000 herein.

It should be apparent from the foregoing that the devices according tothe various embodiments will provide the benefits allowing treatingphysicians to provide office-based treatment of patients withoutsedation, as for example when the device or portion thereof aredisposable, and sterilization is avoided, and also when the diametercoupled with the flexible nature permits entry through the nasalpassages in the esophagus. Such devices can lower total cost treatmentmethod by avoiding the cost and facility for general anesthesia. Incertain embodiments, the use of disposable sheath to cover a re-usabledevice saves costs. Further, the physicians ease of use will be enhancedwith only a single catheter to manipulate vs. multiplecatheters/instruments that may need to be separately sterilized andprovided by an assistant.

It should be understood that an endoscope is in essence an externalcontrol device for manipulating one or more aspects of a catheter forinsertion in a natural body cavity or surgical body opening, and viewingan aspect of tissues prior to or during a contemplated medicalprocedure.

A contemplated use of various embodiment of the invention are forcryotherapeutic treatment of Barrett's esophagus, which involves thecontrolled application of a liquid freezing agent, usually liquidnitrogen, to selected tissue visualized with an endoscope.Conventionally, the treatment is done by introducing the catheter end ofthe endoscope orally, identify the tissue needing treatment, andintroducing additional catheters to locally introduce the liquidnitrogen, as well as capture and direct the expanding gas from theheated liquid treatment region of the patient.

The improvement in various embodiments that follow will enable treatmentwithout sedation in an office environment by using one of moredisposable components in generally a single endoscope device. Thepreferred embodiments of such catheters are configured for nasal entry.According, in various embodiments the total outer diameter of the tubeis less than about 10 mm, but preferably less than about 8 mm and morepreferably less than about 6 mm for nasal entry.

In accordance with the present invention the endoscopy device 1000comprises a controller 100 and a coupled catheter member 1200 formed ofa tube 1210 with an outer wall 1211, multiple parallel lumens 1220including at least a first lumen 1221 adjacent the outer wall 1211 ofthe tube 1210. The first lumen 1210 is optionally open via portal 1217at the distal end of the tube and the proximal end in communication withthe controller for the controlled introduction of tools or materials. Aplurality of perforation 1215 in the wall 1211 of the tube 1210 thatpenetrate to the first lumen 1221. With reference to the distal end ofthe catheter member 1200 most distal from the controller 1100 device,the first lumen 1221 may extend upward to release gas adjacent theproximal end of the tube outside of a patient. It should also beappreciated that multiple parallel lumens 1220 may including at least afirst lumen 1221 adjacent the outer wall 1211 of the tube 1210. Thecontroller 100 may have one, two or three external ports incommunications with the various lumens, such as for inserting tools,releasing gas formed in or from a cryo-treatment, as well as inserting afluid, either as a gas or liquid into a lumen.

In the preferred embodiment illustrate in FIG. 5, a first 1221 andsecond lumens 1222 are disposed at least partially on opposing sides ofthe tube wall have perforations 1215 through the wall 1211. The couplecatheter member 1200 preferably has a working length of at least aboutbetween 55 and 115 cm. The length of at least about 55 cm allows it toreach the esophagus of most patients, whereas the longer working lengthof at least about 115 cm also allows it to reach the cardia/duodenum.

Other aspect of the invention in various embodiment may include guidewires 1301 and 1401 in at least two of the lumens 1300 and 1400, whichare disposed adjacent to the tube wall 1211 on opposite sides of thetube 1210, as illustrate in FIG. 4. For example, each of the first andsecond lumens partially surround the opposing pair of lumens havingguide wires. The control actuator/hand-piece that receives the tubes maydeploy conventional means to engage the guide wires.

The remaining lumens 1230 and 1240 are for imaging and fluid spray meansand may be disposed between the first and second lumens. Lumen 1230 isopen at portal 1237 to introduce a tool or material, whereas lumen 1240is for imaging and generally contain fiber optic imaging lens or camera200 and Light Emitting Diodes (LED) 251 and 252 or optical fibers usedto transmit light from LED's in the controller 100.

It should be noted that the remaining lumens 1230 and 1240 are disposedadjacent to a central axis of the tube 1210 such that they are at leastpartially surround by the first and second lumens 1221 and 1222. Aliquid freezing agent may be introduced directly via lumen 1230 or 1240or another tube with a spray orifice guided into the lumen 1230, asillustrated and described further below. Such delivery of the liquidfreezing agent may be by any fluid spray means optionally in anotherlumen at the distal end of the tube.

In any of the above and following embodiment the imaging means is amicro-camera or a fiber optic imaging device 200. The imaging means is acamera 200 that captures light outside of the visible spectrum, such asinfrared light. Infrared imaging provides user with pathologydifferentiation for precise delivery of fluid freezing agent or othercryotherapeutic fluid, such as a cold liquid that becomes a gas onwarming (for example liquid nitrogen), or a cold gas (such as carbondioxide). Infrared imaging can provide user with visual indication ofwhere cryotherapeutic liquid has already been delivered because thefrozen tissue is colder, and remains cold until it is warmed byconduction, as it lacks vessel to warm by the convection from bloodflow, as the blood capillaries are destroyed by freezing. Alternativeimaging modalities to visible light (Optical Coherence Tomography,chromoendoscopy, etc) for indicating pathological tissue to target withcryogenic fluid.

FIG. 6-12 illustrate another embodiment of the invention in which adevice 1000 has a disposable protective portion 1500 that cover thepermanent portion 1600, avoiding the need to sterilize the devicedisposable lumen with a sealed protective sheath for a re-usablecatheter with the imaging and illumination means.

As the lumen for the permanent member 1600 is sealed at the distal endand side, it keeps the permanent member 1600 isolated from the body toavoid the need for sterilization

The permanent portion 1600 is an elongated endoscopic catheter tube 1210with a “D” shape that has imaging and illumination means. The disposableprotective portion 1500 is a subdivided tubular sheath with a D shapedlumen 1501 to receive the permanent portion 1600 with a clear window1510 on the end of the tube. The sheath 1500 has a lumen 1520 with adistal opening 1525. Lumen 1520 may also have side openings 1215.Alternatively, as shown in FIG. 10 and FIG. 11A-C, tube 1210 may includeanother lumen 1530 with side opening 1215 that runs parallel to thelumen 1220 with the distal opening. In this case lumen 1520 can besealed at the side wall 1211 of the tube 1210 or by surrounding walls oflumen 1530. A treatment agent or tool can be introduced via lumen 1520.For example, the elongated tube 1900 with an end opening 1901 such asshown in FIG. 21 may be introduced into lumen 1520. Lumen 1520 that isused to deliver a cryo-fluid may also have a heater coil 1700, as isfurther discussed with respect to FIG. 13A-C and FIG. 14.

It should be appreciated the disposable portion 1500 may be constructedby adhering or fusing the distal end of tubular member 1512 to a tipportion 1511, each of which is illustrated in transverse sectional viewsin FIGS. 11C and 11B respectively. The tip 1511 with the window 1510 canbe fabricate by casting resin or another form of molding, including 3-Dprinting, around a rigid glass or plastic window, 1510, and member 1512(or 1210) can be made by co-extruding plastic resin to form the outerdiameter of the tube and the connected interior lumens. Alternatively,tube 1512 or 1210 can be made by laminating tubes of other extrudedprofile that are closed to form lumens to an elongated flexible plasticmember. The plastic member can be rolled transversely to connect to theopposite edge or another lumen to form the tube, with an edge seamformed by ultrasonic welding or adhering with adhesive resin. Theinitial lamination before rolling into a tube can be forms by adhesivelylaminating multiple tubes to one of each other and the elongated plasticmember, or co-extruding the elongated plastic member around thepreformed tubing. The preformed tubing can be chemically or radiationcross linked after extrusion to avoid melting during co-extrusion.Mechanical control and power or signal transmitting wires, or opticalfiber wires can also be co-extruded around or inserted after forming, orbefore any step of forming the tubular lumen 1210, such as by rolling ora final extrusion step. Perforation 1215 can readily be formed by laserablation at any stage in fabrication, whereas punching out ofperforations with mating dies is preferably performed with a plasticmember before it is rolled into a tube.

FIG. 13A-C and FIG. 14 illustrate other preferred embodiments of thecatheter for use with any of the embodiment of the device 1000, mayinclude a heater means 1700 to prevent the clogging of the lumen fromfrozen bodily fluid or treating agent, or fluid or saline solution thatmight be used to clear the operating field. The heating means ispreferably resistance heater coils 1701 connected by a circuit to apower source at the controller 100. Alternative locations for placingthe heater coils is in the outer wall of the tube, or in the cryo-fluiddelivery lumen 1230. FIG. 13A-C illustrate such embodiments in which theheater 1701 can be in any lumen used for cryo or liquid treating agent.Alternative placements of the wire 1710 that form the circuit between apower supply and the control 100 with the heater elements 1701, such ascoils, may be inside a lumen, fused to the interior of lumen wall, orwithin the walls that define the lumen opening. Such heating wire can beexternally wrapped or wound around the tube 1210, and then overcoat witha thin layer of resin or varnish to become a part of the device 1210.Electrical connections to extruded wire in the tube 2010 can be madebefore such overcoating.

FIG. 15-20 illustrate embodiments of a fixation and/or dilation means1800 near the distal end of the tube. The fixation means may be anexpandable tubular body 1810 that surrounds the exterior of the tube1210, and includes a means to selectively pressurize and deflate theinflation fixation means, such as a tube 1820 in fluid communicationwith a source of pressure at the controller 100. Placement of theinflation fixation means or tube 1810 from the distal end of the tube isat least about 10 mm (more preferably at least 20 mm, and mostpreferably at least 30 mm). Pressurization can be with gas (air ornitrogen for example) or a fluid (water for example). Such a fixationmeans may be an expandable tubular member or body 1810 in fluidcommunication with another lumen 1820 that extends toward the proximalend of the tube or an external cannula 1830 (FIG. 19) that is fused tothe outer wall of the tube to extend from about the proximal end to forma fluid connection with the inflation fixation means. Lumens 1820 or1830 may extend along or in the tube 1210 to the controller 100, butwill have a lateral opening 1825 into the expandable tubular member1810. The expanded tubular member 1810 may have a convoluted wall orsurface when not expanded, as shown in FIG. 16A, but can form a smoothuniform curvilinear surface when expanded as shown in FIG. 16B. Theexpanded tubular member 1810 member may be configured to form any shapewhen inflated via lumen 1820 or 1830.

As some treatment modalities may results in strictures when new tissueon walls of the healing esophagus has a tendency to adhere narrowing orpartially closing the esophageal passage, another aspect of theinvention is a device and method of the opening such stricturesmechanically by the inflation and fixation means, either as a separatetreatment, or as a preliminary step in any of the aforementioned orfuture treatment processes.

In addition to the method of introducing a liquid freezing agent fortreatment after introducing the tube 1210, imagining the area to betreated, and fixing the tube 120 if necessary, the treatment method caninclude stricture opening with the inflatable fixation means prior tostarting any treatment or alone as a treatment. Such treatments, with orwithout the need for treating strictures may include alternativetreatment modalities to cryogenics include RF ablation, photodynamictherapy. It should also be appreciated that such treatments may includeapplication of negative pressure to aide in evacuation of fluids fromwithin the patient via any lumen open at the distal end of tube 1210.

It should now be appreciated that aspects of the invention includemethods of using an endoscopy tube or a covered endoscopy tube that isinserted into a body cavity of a patient from the nasal cavity of thepatient and the body cavity is the esophagus.

Another aspect of the invention is a method of using an endoscopy tubeor a covered endoscopy tube that is inserted into a body cavity of apatient from the mouth of the patient and the body cavity is at leastone lung.

As such treatment may require the ability to locate the structure tooptimally place the balloon member 1800 before expansion, FIG. 16B-FIG.17B illustrate alternative locations for placing a second camera such as201 in the balloon 1800, or above the balloon for camera 202 as shown inFIGS. 17A and 17B. Accordingly, the device illustrate in FIG. 15A to 18can be used for locating the area that requires dilation with any ofcameras 200, 201 and 202, inflating the balloon 1200 to open a strictureand withdrawal of the device, either a stand alone treatment, or as astep prior to subsequent treatment of the underlying condition at orproximal to the point of stricture that was opened.

FIG. 21 illustrates another embodiment of the invention that providesplacement of treatment modality tool 1901 beyond the camera 200 to imagethe progress of treatment. A fluid spray means (or a tool for anyalternative treatment modality, such as without limitation, electrodesor photo therapy illumination means), such as a nozzle 1901 can beinserted via lumen 1230 beyond the distal end of the tube 1210 so theregion of the spray application of the liquid freezing agent, isaccessible to the imaging means, such as camera 200.

Alternatively, the lumen 1230 that is used to introduce a liquidfreezing agent or other treatment modality can be fixed to extend pastthe lumen 1230 with the imaging means, such as camera 200 and LightEmitting Diodes 251 and 252.

FIG. 22A and FIG. 22B are intended to illustrate, in an isometric viewof another embodiment of the invention, that the applicator tip 1901 ofFIG. 21 can be advanced beyond the imaging means at the distal end ofthe tube 1200 from a portion 1601 through a lumen 1630 open at end 1610so that fluid enters via lumen 1230. FIG. 22B shows the alignment oflumens 1230 and 1630. In the embodiment of the invention of FIGS. 24Aand 24B, the device 1000 has disposable protective portion 1500 thatcovers the permanent portion 1600, avoiding the need to sterilize thedevice disposable lumen with a sealed protective sheath for a re-usablecatheter with the imaging and illumination means. As a lumen 1501 forthe permanent member 1600 is sealed at the distal end and side, it keepsthe permanent member 1600 isolated from the body to avoid the need forsterilization. The permanent portion 1600 is an elongated endoscopiccatheter tube with a “D” shape that has imaging and illumination means.The disposable protective portion 1500 is a subdivided tubular sheathwith a D shaped lumen 1501 to receive the permanent portion 1600 with aclear window 1510 at the distal end. The sheath 1500 has lumens 1520 and1530 that extends parallel to the D shaped lumen 1501. Lumen 1520 is forthe fluid spray means and extends though lumen 1530 to the distalopening 1525. The sealed lumen 1501 is for the imaging means andcontains the guide wires 1301 and 1401 that are coupled to the imagingmeans and is terminated in a sealed window 1510 for protecting theimaging means, which includes camera 200 and LED's 251 and 252. Lumen1530 has the perforations 1525 in the outer wall of the s disposableprotective portion or sheath 1500.

FIG. 23 illustrates another embodiment of the tube 1210 in section viewwith two guide wires 1301 and 1401 roughly opposed within a first lumen1221. This first lumen is defined by the outer wall 1211 of the tube1210. The two guide wires 1301 and 1401 allow articulation by tension atthe controller 100. Lumens 1230 and 1240 are for imaging means and fluidspray means, such as cryogen delivery, respectively and also may bedisposed within a first lumen 1221. Lumen 1230 may contain or bereplaced by electrical and/or fiber optical cable for the imagingsystem. The outer wall 1211 will have a plurality of perforation 1215that penetrate to the first lumen 1221 generally around the distalportion to accept the expanding gasses from the evaporating cryogenafter delivery to the outside of the tube 1200 via an exit orifice oflumen 1240. These tubes that form lumens 1230 and 1240 or cables andlumen 1240 are fixed in place adjacent opposing end of the tube 1210, asare guide wires 1301 and 1401, and can move within the inner space ofthe catheter between the two ends. This inner free space with theinterior of the should generally be greater than about 6 mm² to workclinically and evacuate the expanding gas that formed on the warming ofthe liquid freezing agent introduced by the fluid spray means. By innerfree space we mean the area within the interior side of the outer wall,minus the area of the guide wires and smaller interior lumens. However,if the total area within the outer diameter of the tube is over about120 mm² would be too large to fit into the mouth or nose of mostpatients.

Although the various and preferred aspects of the various embodimentshave been discussed with respect to use as an endoscope, nothingprecludes their use as a laparoscope, a portion of a laparoscope or in alaparoscopic procedure.

While the invention has been described in connection with a preferredembodiment, it is not intended to limit the scope of the invention tothe particular form set forth, but on the contrary, it is intended tocover such alternatives, modifications, and equivalents as may be withinthe spirit and scope of the invention as defined by the appended claims.

We claim:
 1. A flexible tubular member for endoscopic procedures, themember comprising: a) a tube having a proximal end and an opposingdistal end with an outer wall extending between the ends, the tubehaving an outer diameter of less than about 10 mm, b) multiple parallellumens that extend generally between the proximal and distal ends of thetube, including; c) at least one lumen having a plurality ofperforations through the outer wall adjacent the distal end of the tube,d) a pair of guide wires disposed to extend from about the distal end ofthe tube to the proximal end of the tube, e) two or more remaininglumens which respectively provide at the distal end of the tube for animaging means and a fluid spray means, wherein the multiple parallellumens that extend generally between the proximal and distal ends of thetube, include; i) a first central lumen with a bore of a first diameterthat disposed within a ovoid member, the ovoid member being connected ata top and bottom to the outer wall of the tube, ii) a second centrallumen with a bore of a second diameter that is smaller than the firstdiameter, the second lumen being disposed within the ovoid member andadjacent to the first central member, iii) wherein the at least onelumen having a plurality of perforations through the outer wall adjacentthe distal end of the tube comprises a pair of generally lobe shapedelongated lumens, each being disposed between opposing sides of theouter wall of the tube and an adjacent side of the ovoid member, one ofsaid pair being the first lumen having a plurality of perforationsthrough the outer wall adjacent the distal end of the tube, and theother of the pair being an additional lumen having a plurality ofperforations through the outer wall adjacent the distal end of the tube.2. The flexible tubular member for endoscopic procedures according toclaim 1 and further comprising an inflation fixation means disposed atleast about 10 mm from the distal end of the tube.
 3. The flexibletubular member for endoscopic procedures according to claim 1 whereineach of the guide wires of the pair are disposed in an opposite side ofthe outer wall of the tube adjacent each of the lobe shaped elongatedlumens in which each guide wire is surrounded by tube outer wall suchthat an inner portion of the tube wall projects as a protuberance intoeach of the generally lobe shaped elongated lumens to narrow the widthof each of the generally lobe shaped elongated lumens adjacent the guidewire in the tube wall.
 4. The flexible tubular member for endoscopicprocedures according to claim 1 wherein the first central lumen has adischarge portal adjacent the distal end of the tube and a receivingportal at the proximal end of the tube.
 5. The flexible tubular memberfor endoscopic procedures according to claim 1 that has a length of atleast about 55 cm.
 6. The flexible tubular member for endoscopicprocedures according to claim 1 that has a length of less than about 115cm.
 7. The flexible tubular member for endoscopic procedures accordingto claim 1 wherein the tube is an outer sheath divided along the lengththereof into; a. the lumen for the imaging means that is sealed andcontains the pair of guide wires, b. the lumen having the perforationsin the outer wall of the tube, in which the lumen for the fluid spraymeans extends though the lumen having the plurality of perforationsthrough the outer wall.
 8. The flexible tubular member for endoscopicprocedures according to claim 1 that has an outer diameter of less thanabout 10 mm.
 9. The flexible tubular member for endoscopic proceduresaccording to claim 1 wherein the one of the two or more remaining lumensfor the fluid spray means has an interior cross-sectional areatransverse to the lumen of at least about 6 mm².
 10. The flexibletubular member for endoscopic procedures according to claim 1 whereinthe lumen for the fluid spray means comprises a heating means.
 11. Theflexible tubular member for endoscopic procedures a) a tube having aproximal end and an opposing distal end with an outer wall extendingbetween the ends, the tube having an outer diameter of less than about10 mm, b) multiple parallel lumens that extend generally between theproximal and distal ends of the tube, including; c) at least one lumenhaving a plurality of perforations through the outer wall adjacent thedistal end of the tube, d) a pair of guide wires disposed to extend fromabout the distal end of the tube to the proximal end of the tube, e) twoor more remaining lumens which respectively provide at the distal end ofthe tube for an imaging means and a fluid spray means, f) an inflationfixation means disposed at least about 10 mm from the distal end of thetube, a. in which the lumen for the imaging means is sealed and containsthe pair of guide wires, b. in which the lumen for the fluid spray meansextends though the lumen having the plurality of perforations throughthe outer wall, and wherein the plurality of perforations through theouter wall adjacent of the tube are disposed between the inflationfixation means and the distal end of the tube.
 12. The flexible tubularmember for endoscopic procedures according to claim 11 wherein the lumenfor the fluid spray means comprises a heating means.
 13. A flexibletubular member for endoscopic procedures, the member comprising: a) atube having a proximal end and an opposing distal end with an outer wallextending between the ends, the tube having an outer diameter of lessthan about 10 mm, b) multiple parallel lumens that extend generallybetween the proximal and distal ends of the tube, including; c) at leastone lumen having a plurality of perforations through the outer walladjacent the distal end of the tube that are not covered by aninflatable fixation means, d) a pair of guide wires disposed to extendfrom about the distal end of the tube to the proximal end of the tube,e) two or more remaining lumens, one containing an imaging means at thedistal end of the tube and the other containing a fluid spray means atthe distal end of the tube wherein the tube is an outer sheath dividedalong the length thereof into; a. the lumen for the imaging means thatis sealed and contains the pair of guide wires, b. in which the lumenfor the fluid spray means extends though the lumen having the pluralityof perforations through the outer wall.
 14. A device for endoscopicprocedures that is inserted into a body cavity, the device comprising:a) a tube having a proximal end and an opposing distal end with an outerwall extending between the ends, the tube having an outer diameter ofless than about 10 mm, including; i) multiple parallel lumens thatextend generally between the proximal and distal ends of the tube,including; ii) at least one lumen having a plurality of perforationsthrough the outer wall adjacent the distal end of the tube that are notcovered by an inflatable fixation means so as to be in direct fluidcommunication with the body cavity, ii) a pair of guide wires disposedto extend from about the distal end of the tube to the proximal end ofthe tube, iii) two or more remaining lumens, one containing an imagingmeans at the distal end of the tube and the other containing a fluidspray means at the distal end of the tube; b) a controller connected tothe proximal end of the tube that is operatively connected to the pairof guide wires, c) a source of fluid connected at the proximal end ofthe tube to the lumen containing the fluid spray means at the distal endof the tube in which the lumen for the imaging means is sealed andcontains the pair of guide wires, and the lumen for the fluid spraymeans extends though the lumen having the plurality of perforationsthrough the outer wall.
 15. The device for endoscopic procedures that isinserted into a body cavity according to claim 14 and further comprisingan inflation fixation means disposed at least about 10 mm from thedistal end of the tube.
 16. A device for endoscopic procedures that isinserted into a body cavity, the device comprising: a) a tube having aproximal end and an opposing distal end with an outer wall extendingbetween the ends, including; i) multiple parallel lumens that extendgenerally between the proximal and distal ends of the tube, including;ii) at least one lumen having a plurality of perforations through theouter wall adjacent the distal end of the tube that are not covered byan inflatable fixation means so as to be in direct fluid communicationwith the body cavity, iii) a pair of guide wires disposed to extend fromabout the distal end of the tube to the proximal end of the tube, iv)two or more remaining lumens, one containing an imaging means at thedistal end of the tube and the other containing a fluid spray means atthe distal end of the tube, b) a controller connected to the proximalend of the tube the is operatively connected to the pair of guide wires,c) a source of fluid connected at the proximal end of the tube to thelumen containing the fluid spray means at the distal end of the tube,wherein the lumen for the fluid spray means comprises a heating means.